Effect of a SI-MMC on the IVR Rate After Ureteroscopy for UTUC

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

About this trial

The goal of this observational study is to evaluate the intravesical recurrence (IVR) rate after ureteroscopy (diagnostic or treatment) for upper tract urothelial carcinoma (UTUC) followed by an adjuvant single instillation of Mitomycin C (SI-MMC).

The main question it aims to answer are:

* What is the total and time to IVR after 2 years after ureteroscopy (diagnostic or treatment) for UTUC * How is the IVR compared with a historical cohort (no SI-MMC) * What is the time to IVR after 2 years in patients who subsequently received treatment by endoscopy vs. radical nephroureterectomy (RNU) * What is the additional value of a SI-MMC on time to IVR after RNU + adjuvant MMC in patients who were evaluated by ureteroscopy prior to RNU

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All patients suspect for having non-metastatic disease and planned for ureteroscopy (diagnostic or treatment) and adjuvant single instillation of Mitomycin C

Age ≥18 years

Written informed consent

Disqualifiers

History of histological proven urothelial carcinoma of the bladder, including carcinoma in situ

History of histological proven UTUC in the contralateral kidney

Concurrent bladder tumour found pre-operatively or per-operatively

Patients where it is not feasible to obtain histology by biopsies intra-operatively

Trial population

Patients suspect of having non-metastatic UTUC

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Time to and total number of Intravesical recurrences (IVR)

What is the time to and total number of IVR 2 years after ureteroscopy (diagnostic or treatment) with SI-MMC for UTUC

Time frame
2 years
2

Time to and total number of IVR after endoscopic vs radical treatment

What is the time to and total number of IVR after 2 years in patients who subsequently received treatment by endoscopy vs. radical nephroureterectomy

Time frame
2 years
3

Time to and total IVR after diagnostic ureteroscopy in patients who received final treatment by RNU

Is there an additional value of SI-MMC on total and time to IVR after RNU in patients who were evaluated by ureteroscopy prior to RNU. Outcome measurement (time to IVR and total IVR) will be compared to a historical cohort who did not receive Mitomycin C to evaluate the additional effect

Time frame
2 years

Secondary outcomes

1

predictive factors for IVR

to evaluate possible predictive factors for IVR rate looking different variables by multivariate logistic regression; with the dependent variable IVR and independent variables: gender (male/ female), tumour size (\< 2cm/ \>2cm), tumour focality (unifocal/ multifocal), tumour invasiveness (invasive/ non-invasive), tumour location (ureter/ puelocaliceal), use of Urethral access sheath (yes/no), use of postoperative stent (yes/ no), timing of MMC administartion (\<24h/\>24h)

Time frame
2 years

Other outcomes

Sponsors and contacts

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